End Stage Liver DIseaseNCT05981196
Disparities Among Liver Transplant Patients
An observational study of End Stage Liver DIsease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Liver DIsease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Subjects identified with end-stage liver receiving initial stage of transplant evaluation at Mayo Clinic Arizona.
Who may be able to join
- Patients with end-stage liver, kidney, or cardiac dysfunction.
Who cannot join
- Patients with more than one system with end stage organ dysfunction, dementia, cognitive or sensory impairment, prior solid organ transplant.
- Patients with potential medical exclusions for transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual and Structural-level Determinants Associated With Disparities Among Liver Transplant Patients
The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation.
Read the detailed description
Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.
Aim 2. Examine interpersonal and structural factors associated with liver transplant evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).
Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant based on their demographic characteristics (e.g., race, ethnicity, SES, gender).
- Conditions
- End Stage Liver DIsease
- Keywords
- Transplants, Transplantation, Healthcare Disparities, Minority Health, Communication
- Medical subject headings
- End Stage Liver Disease, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant Patients | Subjects with end-stage liver disease and being referred for transplant evaluation will fill out questionnaires about their background, emotions, and behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transplant waiting list
Number of subjects listed on the liver transplant waiting list
Measured: Approximately one year
Organ transplantation
Number of subject to receive an organ transplantation
Measured: Approximately one year
Secondary outcomes (3)
Survival
Total number of subject alive
Measured: Approximately one year post-transplant, or until you are removed from the transplant list
Graft survival at six months
Total number of subject to have a functioning graft at six months post transplant
Measured: Six months post transplant
Graft survival at one year
Total number of subject to have a functioning graft at one year post transplant
Measured: One year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Nov 2023
- Primary completion25 Jun 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter E. Frasco, Mayo Clinic
- Investigators
- Peter E. Frasco, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981196
- Sponsor's protocol ID
- 22-008581
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Structural-level Determinants Associated With Disparities Among Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT05981196
- Acronym / sponsor ID
- 22-008581
- Conditions
- End Stage Liver DIsease
- Keywords
- Transplants, Transplantation, Healthcare Disparities, Minority Health, Communication
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation.
Detailed description
Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.
Aim 2. Examine interpersonal and structural factors associated with liver transplant evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).
Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant based on their demographic characteristics (e.g., race, ethnicity, SES, gender).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant Patients | – | –Subjects with end-stage liver disease and being referred for transplant evaluation will fill out questionnaires about their background, emotions, and behaviors. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects identified with end-stage liver receiving initial stage of transplant evaluation at Mayo Clinic Arizona.
Key inclusion criteria (1 listed)
- Patients with end-stage liver, kidney, or cardiac dysfunction.
Key exclusion criteria (2 listed)
- Patients with more than one system with end stage organ dysfunction, dementia, cognitive or sensory impairment, prior solid organ transplant.
- Patients with potential medical exclusions for transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver transplant waiting list
Time frame: Approximately one year
Number of subjects listed on the liver transplant waiting list
Organ transplantation
Time frame: Approximately one year
Number of subject to receive an organ transplantation
3 secondary outcomes
Survival
Time frame: Approximately one year post-transplant, or until you are removed from the transplant list
Graft survival at six months
Time frame: Six months post transplant
Graft survival at one year
Time frame: One year post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver DIsease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter E. Frasco, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver transplant waiting list (time frame: Approximately one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.